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Cellutome™

FDA UDI

Class I (US FDA UDI)

by Kci Usa, Inc.

Identity

Trade Name
CELLUTOME™ FDA UDI
Generic Name
Dermatome handpiece, electrically-powered FDA UDI
Device Name
Cellutome Epidermal Harvesting System Control Unit Stand FDA UDI
Model / Reference
CT-CUS1 FDA UDI
Description
Cellutome Epidermal Harvesting System Control Unit Stand FDA UDI

Identifiers

Primary DI / UDI-DI
00849554001176 FDA UDI
FDA Product Code
GFD FDA UDI
GMDN Term
Dermatome handpiece, electrically-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dermatome handpiece, electrically-powered

Cellutome™ by Kci Usa, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatome handpiece, electrically-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kci Usa, Inc.

Sources (1)

  • FDA UDI a558d8eb-937b-469a-a5ce-6587e13f28c7 33 fields · synced May 30, 2026